The Acta Formula
FDA 510(k) K922703 · Biosound, Inc.
510(k) numberK922703
Submission
- Device name
- The Acta Formula
- Applicant
- Biosound, Inc.
Indianapolis, IN, US - Received
- June 5, 1992
- Decision date
- April 27, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
Other 510(k)s with product code DPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional | Edan Instruments, Inc. | 07/02/2026SE |
| K251670 | MAC 7 Resting ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 01/26/2026SE |
| K252361 | AccurECG Analysis System (v2.0)DPS · Traditional | Accurkardia, Inc. | 12/22/2025SE |
| K252474 | Withings BeamO (SCT02)DPS · Traditional | Withings | 11/10/2025SE |
| K250569 | Cardiologs Holter PlatformDPS · Traditional | Philips France Commercial | 08/06/2025SE |
| K243252 | ZBPro DiagnosticDPS · Traditional | Zbeats, Inc. | 07/10/2025SE |
| K243305 | Masimo W1DPS · Traditional | Masimo Corporation | 04/03/2025SE |
| K241217 | CloudHRV System (100-01-001)DPS · Traditional | Inmedix, Inc. | 01/16/2025SE |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional | Philips Medizin Systeme Böblingen GmbH | 12/17/2024SE |
| K240229 | Masimo W1DPS · Traditional | Masimo Corporation | 08/08/2024SE |
More from Masimo Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K971700 | Biopsy Accessory for Ultrasound TransducerITX · Traditional | 07/09/1997SE |
| K963936 | Accesspoint, Med E-Mail, Dicom ReaderLMB · Traditional | 03/31/1997SE |
| K963262 | Artoscan MLNH · Traditional | 03/28/1997SE |
| K963662 | Galileo Evoked PotentialreGWF · Traditional | 02/26/1997SE |
| K953716 | Intracavity TransducersITX · Traditional | 04/17/1996SE |
| K953530 | Diagnostic Ultrasound Tranducers P10A, P12A, PT10A, PA11-AIYO · Traditional | 04/08/1996SE |
| K953819 | Diagnostic Ultrasound TranducerITX · Traditional | 03/01/1996SE |
| K953759 | Diagnostic Ultrasound TransducerITX · Traditional | 03/01/1996SE |
| K955458 | Ultrasound Probe Biopsy AccessoriesITX · Traditional | 02/12/1996SE |
| K953579 | Tee ProbeITX · Traditional | 02/02/1996SE |
Questions and answers
When was The Acta Formula cleared by the FDA?
The Acta Formula (K922703) received a 510(k) decision of Substantially Equivalent on April 27, 1993, 326 days after the submission was received.
What is the product code of K922703?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.